Medical Devices

Washington D.C. Attorneys and Advisors to FDA-Regulated Industries

The development, manufacturing, and marketing of a medical device require an in-depth understanding of the Food and Drug Administration (FDA) regulatory process, as well as the ability to interact effectively with FDA personnel. At OFW Law, our attorneys provide comprehensive counseling and advocacy on FDA medical device matters, ranging from product clearance and approval to postmarket requirements, enforcement and compliance issues, and product promotion and advertising issues.

Development of strategies to bring medical devices to market, pre-submission advocacy with key FDA officials, and preparation of necessary regulatory filings, such as:

Investigational Device Exemption (IDE) applications

Premarket Approval Applications (PMAs)

Premarket Notification Submissions (510(k)s)

Humanitarian Device Exemptions (HDEs)

Compliance with Medical Device Reporting (MDR) requirements, including employee education and system audits

Classification and reclassification of medical devices

Compliance with Quality System Regulation (QSR) requirements, including employee education and system audits

Pre- and post-distribution issues regarding the labeling, advertising, and promotion of medical devices

Highly specialized medical device regulatory matters, such as:

Medical software, including mobile medical apps

In vitro diagnostics

Combination products

Custom devices

Managing risks associated with and responding to FDA enforcement and advisory actions, including Warning Letters and untitled compliance letters

Preparing for and managing FDA inspections, including:

Conducting pre-inspection audits

Assisting during inspections

Drafting responses to Forms FDA 483 (inspectional observations)

Conducting product recalls and other field actions

Medical device listing and establishment registration requirements

Medical device import and export issues, such as:

Export of unapproved devices

Import detentions

Import Alerts (automatic detention)

Import for export

Re-importation

Matters concerning clinical trials, such as:

Compliance with clinical trial requirements

Investigator disqualifications

Legislative Advocacy for the Medical Device Industry

At OFW Law, our attorneys are experienced participants in the legislative process and have played a key role in the enactment of seminal medical device legislation, including the Safe Medical Devices Act of 1990, the Medical Device User Fee and Modernization Act of 2002, and the Medical Device User Fee Stabilization Act of 2005.

Related To Medical Devices

Welcome to OFW Law

OFW Law provides legal, regulatory, and bipartisan government affairs representation to companies, individuals, and trade associations in the agriculture, food, drug, medical device, and health care industries, including representation of the interests of modern agriculture in matters involving environmental law.

The experience of our attorneys and policy advisors, who have backgrounds in government, industry, science and medicine, coupled with proactive, responsive and effective service, has helped OFW Law build a reputation for depth and subject matter expertise. Read More

Awards and Associations

Recent Blog Posts

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As initially announced last week by outgoing Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., the compliance dates for FDA’s agricultural water quality requirements under the “Standards for the Growing, Harvesting, Packing…
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